Regulatory Affairs Associate Require @Teva
Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.
Post : Regulatory Affairs Associate I
The opportunity
• Support EU Generics Labeling Managers and Labeling Germany Managers in providing pharmaceutically and medically accurate product labelling, especially for multiple regulatory procedures of one INN.
• Manage translations for Centralized Procedures (CPs).
Editorial Tasks
• Perform various editorial tasks.
• Review of SmPC and PIL as well as packaging materials using a review protocol.
• Adapt texts to the current QRD template.
• Proofread texts.
• Prompt provision of product information and comments in regulatory database (GRIDS).
• Responsibilities under the role of super-editor (GRIDS).
• Coordinate and handle inquiries from other departments, locations, and service providers.
Screening for innovations in the EU regulatory environment
• Monitoring of the literature (guidelines, best-practices) in the regulatory affairs environment for innovations, especially in the
area of central approvals.
Translation Management for EU Centralized Procedures
• Planning of all process steps after receiving the translation request.
• Coordinate translations of English product information into the languages of EU member states, including Norway and Iceland, for CPs.
• Internal QC check: coordination of communication between all stakeholders (local Markets, translation agency).
• Coordinate linguistic reviews.
• Evaluate translation tables from translation agency and/or local markets.
• Providing necessary documents for submission (e. g. WORD annotated, PDF clean, translation tables).
SAP
• Cost Center Administrator (release of invoices, accounting).
ARIBA
• Management of purchase requisitions within the framework of service contracts (e.g. translations).
Work in a team environment.
Perform all other job-related duties as required by management and dictated by process changes.
Candidate Profile
• Experience in Regulatory Affairs or basic knowledge of European pharmaceutical law and the regulatory affairs environment.
• Completed training as a pharmaceutical-technical assistant or medical assistant.
• Intermediate to advanced English skills (spoken and written), excellent MS Office skills, basic knowledge of European pharmaceutical law and regulatory affairs, project management experience.
Additional Information
Job Id : 62841
Qualification : Pharmaceutical-technical assistant or medical assistant
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 20th August 2025